The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Evolution Medium Steam Sterilizer, Model Hc-900 And Hc-1200.
| Device ID | K091136 |
| 510k Number | K091136 |
| Device Name: | AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 |
| Classification | Sterilizer, Steam |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | Robert F Sullivan |
| Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-20 |
| Decision Date | 2009-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151638 | K091136 | 000 |
| 07350109400236 | K091136 | 000 |
| 07350109400243 | K091136 | 000 |
| 07350109400250 | K091136 | 000 |
| 00724995150549 | K091136 | 000 |
| 00724995150556 | K091136 | 000 |
| 00724995150563 | K091136 | 000 |
| 00724995150570 | K091136 | 000 |
| 00724995150587 | K091136 | 000 |
| 00724995150594 | K091136 | 000 |
| 00724995150600 | K091136 | 000 |
| 00724995150617 | K091136 | 000 |
| 00724995151508 | K091136 | 000 |
| 00724995151515 | K091136 | 000 |
| 00724995151621 | K091136 | 000 |
| 07350109400229 | K091136 | 000 |